Advanced Manufacturing and Biocompatible Parts for the Pharmaceutical and Medical Sector
Ineo offers advanced 3D manufacturing, along with other technologies, for the medical and pharmaceutical sector. We produce biocompatible parts and prototypes with materials meeting sanitary regulations.
At Ineo, we help the medical and pharmaceutical sector through high-precision advanced and additive manufacturing solutions. Based on complex medical data, such as magnetic resonance imaging and digitalized scans, we develop customized surgical cutting guides and anatomical bone replicas in advanced, biocompatible materials, designed to emulate bone elasticity modulus in mechanical testing.
Our technological capability ranges from small-batch production of custom splints, orthoses, and podiatry insoles, to specialized manufacturing of dental splints and nasal adapters for leading firms such as Smile. Likewise, we supply stainless steel trays for instruments and critical components for medical diagnostic equipment—such as camera heads for colonoscopies—always using biocompatible polymers and sanitary-grade resins that guarantee maximum safety and functionality in clinical environments.
Prototypes for the Pharmaceutical and Medical Industry
At Ineo, we collaborate with laboratories, engineering firms, and medical device manufacturers to accelerate their innovation cycles through the development of high-fidelity functional and aesthetic prototypes. We understand that in the biosanitary environment, a prototype must validate not only form, but also mechanical behavior and interaction with chemical substances or sterilization processes.
We create functional and aesthetic prototypes for pharmaceutical equipment, medical devices, and critical laboratory parts. Our advanced technologies allow us to produce precise, resistant parts ready for testing, accelerating the development of pharmaceutical products and processes.

Series Production of Technical and Sanitary Components
At Ineo, we help consolidate your supply chains through the series production of functional components and critical parts for laboratories, analysis equipment, and medical devices. The biosanitary sector demands absolute repeatability; therefore, our processes are designed to ensure all parts are identical to the first and to the approved prototype.
To achieve this most efficiently, we eliminate traditional manufacturing barriers by combining advanced technologies under a hybrid production approach.

Components and Parts for Manufacturing Machinery
To optimize performance and maintain operational continuity of packaging, filling, and automated processing lines in pharmaceutical and medical plants, we supply technical spare parts and custom tooling designed to withstand daily wear and tear, CIP/SIP (cleaning and sterilization in-place) cleaning cycles, and direct contact with the product.
Thanks to the flexibility of our CNC machining processes and advanced additive technologies, we can manufacture critical components that prevent unexpected technical shutdowns and optimize machinery efficiency.
All our components are manufactured under the strictest quality standards, using advanced materials with FDA approval and biocompatible properties. This guarantees total safety in contact with medications and medical fluids, ensuring that each plastic part, sealing gasket, or custom tooling strictly complies with international sector regulations and maintains maximum purity in the production process.

Regulatory Compliance and Traceability
All our production of biocompatible components and critical parts is managed under strict material control (certified technical plastics and sanitary-grade resins), backed by our ISO 9001 certification, ensuring the necessary documentary traceability for the regulatory validations of the pharmaceutical and medical industry.
ISO 9001 Certification: Our entire management system and manufacturing processes are audited and certified under the ISO 9001 standard. This guarantees absolute standardization, repeatable processes, and rigorous control from the reception of the digital file or raw material to the delivery of the final batch.
FDA-Approved and Biocompatible Materials: We work exclusively with a selection of technical plastics, advanced resins, and elastomers (such as biocompatible silicones) that feature FDA approval and biocompatibility certificates (USP Class VI or equivalent). This ensures components are chemically inert, safe for human or active ingredient contact, and resistant to chemical or autoclave sterilization processes.

Advanced Technologies Applied
We implement the most advanced technologies for the pharmaceutical and medical sector:
Industrial 3D Printing
The key technology for mass customization. It allows the creation of surgical cutting guides micrometrically adapted to the patient's anatomy, custom splints, and functional bone replicas in advanced materials, exactly reproducing the density and behavior of human bone for medical simulations.

High-Precision CNC Machining
Used for manufacturing stainless steel trays for surgical instruments, as well as critical components for pharmaceutical machinery requiring a mirror-polished finish (essential to prevent bacterial proliferation and facilitate CIP/SIP cleaning processes). We also machine technical plastics with micron tolerances for packaging line tooling.

Hybrid Manufacturing
We design complex components through additive manufacturing in biocompatible materials (such as colonoscopy camera heads or vial positioners) and subsequently rectify their critical areas, threads, or fits using CNC machining. This allows us to deliver parts with revolutionary internal geometries but with perfect, airtight fits, optimizing costs and development times.

Vacuum Casting and Prototype Molds
Through agile silicone molds, we produce functional prototypes and short runs of elastic or rigid parts, such as biocompatible silicone sealing gaskets of complex geometry, nasal adapters, or medical device casings. This process guarantees excellent aesthetic finishes and isotropic mechanical properties (uniform in all directions), ideal for clinical trials and tightness tests in controlled environments.

Benefits for the Pharmaceutical Sector
Mitigation of regulatory risk: Working under ISO 9001 certification, controlled environments like the Cleanroom, and FDA-approved materials eliminates uncertainties in quality audits. Each critical component is delivered with the necessary documentation and traceability to streamline regulatory validations.
Drastic reduction of Time-to-Market: Traditionally, validating a new dosing system or medical device required months for designing and manufacturing steel injection molds. Through our rapid prototyping and hybrid manufacturing technologies, we reduce this timeframe to days, enabling mechanical and functional testing with final materials almost immediately.
Operational continuity without technical shutdowns: An obsolete gasket or worn guide in an automatic vial packaging line can cost thousands of euros for every hour of inactivity. We manufacture technical spare parts and custom components (such as biocompatible silicone gaskets resistant to CIP/SIP cycles) urgently, acting as a digital warehouse that ensures supply without needing to accumulate physical stock at the production plant.
Cost optimization in short runs (Customized Batches): Personalization and targeted medications demand increasingly smaller production batches. With industrial 3D printing and vacuum casting, we make the manufacturing of short runs of components, adapters, or tooling economically viable, eliminating high amortization costs of traditional tooling.
Guaranteed hygiene and safety: The design of our high-precision machined and polished components guarantees surfaces with minimum roughness. This prevents accumulation of waste, facilitates total sterilization, and prevents cross-contamination, a critical factor in the processing of active pharmaceutical ingredients (APIs) and sterile products.
Applications in the Pharmaceutical Sector
Automated Packaging, Filling, and Conditioning Lines: Maintenance and optimization of production lines are critical to avoid mechanical stops. We manufacture custom components that optimize product transit and dosing.
Closing, Sealing, and Fluid Conduction Systems: We develop custom flat, o-ring, and special profile sealing gaskets via vacuum casting and prototype molds using biocompatible silicones and elastomers.
Cutting and Technical Dosing Tooling: We supply consumable elements and tooling that require microscopic precision and high physical durability. Manufacturing of precision cutting systems for blister separation, medical tube cutting, or plastic film handling. Dosing nozzles and funnels.
Laboratory Equipment and Quality Control Tooling: Personalized utensils and supports, specifically designed to house special formats of vials, test tubes, or analysis tools lacking standard market solutions. Machined physical templates for visually and quickly verifying correct packaging or plastic component dimensions before entry into the production line.
Applications in the Medical Sector
Preguntas frecuentes (FAQs)
Surgical Planning and High-Fidelity Anatomical Models: We manufacture bone replicas faithfully emulating the elasticity modulus and mechanical behavior of human bone. Ideal for prior simulations, titanium plate forming, and medical training.
Personalized Surgical Instruments: Cutting and positioning guides designed from the patient's exact bone structure. These guides are printed in biocompatible polymers ready for autoclave, allowing surgeons to perform incisions and implant placements with micrometric precision. We also manufacture and custom-machine stainless steel instrument trays for efficient organization, transport, and sterilization of specific intervention instruments.
Orthoses, Prostheses, and Custom Patient Elements: Customized podiatric insoles and orthoses, digitally designed and manufactured using additive technologies combining different densities and flexibilities in a single piece to optimize gait. We produce short runs of dental splints and nasal adapters with high aesthetics and perfect fit using sanitary-grade resins guaranteeing safe, comfortable prolonged use.
Critical Components for Diagnostic and Treatment Equipment: Camera heads for colonoscopies and endoscopies, micro-mechanical parts manufactured via hybrid processes (3D printing + CNC finishing) requiring strict tolerances, absolute watertightness, and resistance to high-level disinfectants. Development of insulating plastic enclosures (casings) and internal structural components for monitors, ultrasound systems, or hospital dosing systems.
Frequently Asked Questions (FAQs)
Get your technical questions answered about our manufacturing processes for the pharmaceutical and medical sectors.
At Ineo, we help mitigate any regulatory risk by coordinating our processes under a strict management system audited with the ISO 9001 certificate. All our production of critical components and biocompatible parts is manufactured using technical plastics and sanitary-grade resins with FDA approval (and USP Class VI certifications). Furthermore, for high-demand projects, production is carried out in a cleanroom (controlled environment), delivering each batch with its corresponding documentary traceability dossier ready for validations by AEMPS (Spanish Agency for Medicines and Health Products) or European regulations.
Do you need to accelerate your medical or pharmaceutical processes without compromising regulatory compliance?
Contact our team to resolve your questions regarding advanced manufacturing for the pharmaceutical and medical sector. Explain your project and discover how we can help you streamline prototype development, optimize critical component production, and scale your industrial series under the strictest quality standards.
INEO PROTOTIPOS S.L.
C/Avenc del Daví, 6 Pol.Ind.Can Petit
Terrassa, Barcelona 08227
Tel. +34 937 337 000
Email: contact@ineo.es
Web: https://www.ineo.es

